Lovastatin

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

LUPIN LIMITED

DUNS Number

675923163

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LUPIN LIMITED

Labeler

Lupin Pharmaceuticals, Inc.

Registrant

LUPIN LIMITED

DUNS Number

677600414

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

68180-467

Application Number

ANDA078296

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2023

Ingredients

LovastatinActive

Code: 9LHU78OQFDClass: ACTIBQuantity: 10 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Lovastatin

Product Details

NDC Product Code

68180-468

Application Number

ANDA078296

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

LovastatinActive

Code: 9LHU78OQFDClass: ACTIBQuantity: 20 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Lovastatin

Product Details

NDC Product Code

68180-469

Application Number

ANDA078296

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2023

Ingredients

LovastatinActive

Code: 9LHU78OQFDClass: ACTIBQuantity: 40 mg in 1 1

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-467-07

LOVASTATIN TABLETS USP

10 mg

Rx only

Bottle of 60 Tablets

NDC 68180-467-07 LOVASTATIN TABLETS USP 10 mg Rx only Bottle of 60 Tablets

NDC 68180-468-07

LOVASTATIN TABLETS USP

20 mg

Rx only

Bottle of 60 Tablets

NDC 68180-468-07 LOVASTATIN TABLETS USP 20 mg Rx only Bottle of 60 Tablets

NDC 68180-469-07

LOVASTATIN TABLETS USP

40 mg

Rx only

Bottle of 60 Tablets

NDC 68180-469-07 LOVASTATIN TABLETS USP 40 mg Rx only Bottle of 60 Tablets

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Lovastatin

FDA Approval Summary

Registrants1

Manufacturing Establishments1

Products3

Lovastatin

Product Details

Lovastatin

Product Details

Lovastatin

Product Details

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL